Low-cost safe blade package for surgical purposes

ABSTRACT

A surgical blade package includes a molded piece and a surgical blade mechanically restrained thereon, forming a subassembly, and this subassembly is received within a pouch. The pouch includes a base opaque paper and an upper transparent plastic &#34;blister&#34; sealed together. The method of manufacturing the surgical blade package includes the steps of providing a molded piece and a surgical blade, attaching the surgical blade onto the molded piece, such that the surgical blade is restrained mechanically, providing a pouch or other container receiving the molded piece and the surgical blade attached thereto, sealing the container, and sterilizing the container with the surgical blade and molded piece therein.

CROSS REFERENCE TO RELATED APPLICATIONS

The present invention is a continuation-in-part of application Ser. No.547,685 filed on Oct. 19, 1995, U.S. Pat. No. 5,662,221, which, in turn,is a continuation-in-part of application Ser. No. 08/435,668 filed May5, 1995, U.S. Pat. No. 5,528,811, which, in turn, is a division ofapplication Ser. No. 245,009 filed May 18, 1994 (the latter applicationhaving issued on Jul. 18, 1995 as U.S. Pat. No. 5,433,321).

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

(Not applicable.)

REFERENCE TO A MICROFICHE APPENDIX SPECIFYING THE TOTAL NUMBER OFMICROFICHE AND TOTAL NUMBER OF FRAMES

(Not applicable.)

BACKGROUND OF THE INVENTION

The present invention relates to a package for a surgical scalpel bladeand, more particularly, to a blade package for safely mounting the bladeon a forwardly-extending cleat on the scalpel.

Surgical scalpel blades are usually packaged individually in an aluminumfoil wrap and are irradiated for sterilization purposes. The sterilefoil wrap is torn open in the operating room ("O.R.") in a hospital orclinic, and the blade is removed and mounted on a surgical scalpel. Thescalpel has a forwardly-projecting portion (referred to in the art as a"cleat") and this cleat is inserted within a longitudinal closed slotformed in the blade, thereby mounting the blade on the scalpel. Theblade is relatively thin and flexible, the cleat on the scalpel has agroove to receive the blade, and the mounting is with a slight "snap"fit or "click".

Some scalpel blades, which are used in microsurgery, are super sharp andare packaged in a molded plastic package consisting of a base and apivoted cover.

The scalpel blades are usually changed several times during a medicalprocedure in the O.R., since it is imperative that the sharpness of theblades be maintained. The blades are usually changed by a nurse or O.R.technician (called the "tech").

Whether the blade is packaged in an aluminum foil or in a molded plasticpackage, the blade is removed therefrom; and during the blade mountingprocess, the tech holds the scalpel in one hand and the blade in theother hand and slips the blade on to the cleat on the scalpel. Theseblades are roughly an inch to an inch-and-a-half long and (of course)are razor sharp, so it is not at all uncommon for the tech to be nickedor cut while mounting one of the blades, thereby causing blood flow.

If the patient is H.I.V.-infected, the tech may sero-convert and becomeH.I.V.-infected leading to the deadly AIDS disease. Conversely, if thetech is an H.I.V. carrier, the patient or the other health careproviders in the O.R. are at risk. The same is true with respect tohepatitis or other infectious diseases.

The nurse or tech is very often under intense pressure in the O.R. andmay become temporarily distracted while in the process of changingblades. This tends to aggravate the existing problem.

BRIEF SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide asafety blade package for a surgical scalpel, thereby avoiding cuts ornicks when installing a new blade on the scalpel.

It is another object of the present invention to provide a safety bladepackage that may be manufactured conveniently and at relatively lowcost, thereby facilitating widespread marketing and distribution.

It is yet another object of the present invention to provide a safetyblade package that is "user friendly" so that the hospital nurses andO.R. techs will immediately understand the use thereof and will readilyappreciate its ease, convenience and safety features.

It is still an object of the present invention to provide a low cost andefficient method of manufacturing a surgical blade package which will beconvenient and safe for use by O.R. personnel during surgery.

In accordance with the teachings of the present invention, a bladepackage for safely mounting a blade on a surgical scalpel is hereindisclosed and claimed, wherein the blade includes a cutting edge andfurther includes a body portion having a slot formed therein, the bodyportion having a rear end portion, and wherein the scalpel has aforwardly-projecting cleat received within the slot in the blade. Theblade package includes a base having a ledge supporting the rear endportion of the blade. The blade further has a hole formed therein; andthe base further has an upstanding pin received in the hole in theblade, thereby mounting the blade on the base and preventing substantialmovement of the blade within the package, and thereby preventing anyinadvertent dulling of the cutting edge on the blade. As a result, thecleat on the scalpel may be inserted within the slot on the blade; andthe scalpel with the blade mounted thereon may be lifted up and awayfrom the base, thereby clearing the hole in the blade from the pin onthe base.

Preferably, a cover is pivotably mounted on the base. The cover has apivot axis which is substantially perpendicular to the pin and spacedtherefrom; and the cover extends partially over the base, substantiallycovering the cutting edge of the blade, and exposing the slot formedwithin the blade, such that the cover is pivoted away from the base asthe scalpel with the blade thereon is lifted away from the base.

In a preferred embodiment, the cover is transparent, such that thecutting edge on the blade is visible through the cover; and the covercarries a cushion bearing against the blade.

The ledge on the base supporting the rear end portion of the blade iscanted downwardly in a direction towards the pin, such that the blade isinclined with respect to the base, thereby facilitating the insertion ofthe cleat on the scalpel into the slot on the blade. Preferably, thebase is provided with a pair of spaced-apart raised lands, one on eachside of the ledge on the base.

The present invention also provides an improved surgical bladecomprising a main body portion having an elongated slot formed therein,a tip and a cutting edge, the elongated slot having a narrowed forwardportion, and a hole formed in the blade between the tip and the narrowedforward portion of the elongated slot.

Viewed in another aspect, the present invention provides an improvedmethod of mounting a blade on a surgical scalpel, wherein the scalpelhas a forwardly-extending cleat. A sterile blade package is opened toobtain a blade package assembly; and this blade package assemblyincludes a base having a blade mounted thereon. The blade has a mainbody portion provided with a longitudinal slot, and the blade furtherhas a tip and a cutting edge. The base is provided with a pivoted covercovering at least the tip of the blade. The cleat on the scalpel isinserted into the longitudinal slot in the blade, so that the blade is"snapped" on to the cleat; and the scalpel with the blade mountedthereon is moved up and away from the base to lift the cover and pivotit away from the base, thereby clearing the scalpel with the bladethereon from the blade package assembly.

In accordance with the further teachings of the present invention, thereis herein disclosed a blade package for a blade used for surgicalpurposes, wherein the blade is intended to be mounted on the cleat of ascalpel handle, and wherein the blade is provided with a slot having aforward portion and is further provided with a tip and a cutting edge.This blade package includes a base, and means are provided on the basefor supporting the blade and assuring that the cutting edge on the bladewill not become dulled by inadvertent contact with the base duringshipment, storage or handling of the blade package. A relatively-thinfilm is secured to the base and covers the blade; and this film isprovided with at least a frangible portion, such that the film may betorn away or lifted up and away from the base to expose the blade.Thereafter, the cleat on the scalpel handle may be inserted into theslot in the blade to mount the blade on the scalpel handle, and theblade thus mounted on the scalpel handle may be lifted out of the baseof the blade package. The blade package is then discarded.

Preferably, the means on the base for supporting the blade and assuringthat the cutting edge on the blade will not become dulled by inadvertentcontact with the base during shipment, storage or handling of the bladepackage, comprises an upstanding pin on the base; and the blade has ahole formed therein to receive the pin.

Preferably, the hole in the blade is disposed between the tip of theblade and the forward portion of the slot in the blade.

Moreover, the base has a rear end wall having a notch formed therein,and the blade further has a rear portion received within the notch.

In a preferred embodiment, an interference fit is provided between thepin and the hole, and between the notch and the rear portion of theblade, respectively, such that the blade is received on the base with a"snap" fit.

The film is transparent, preferably, so that the blade is visible in theblade package; and a tab is provided on the film, such that the tab maybe gripped to rupture the frangible portion of the film and lift thefilm up and away from the base, thereby providing access to the blade.

The base has a peripheral rim, the blade is disposed on the base belowthe rim, and the base has a bottom wall formed with an elevatedcored-out portion supporting the pin.

Preferably, the base has respective sides which are indented concavelytherein and provided with respective serrations, thereby facilitatinggripping of the base.

Viewed in still another aspect, the present invention provides alow-cost, low time-consuming and efficient method of manufacturing a"user friendly", convenient and low cost surgical blade package. Thismethod, according to the teachings of the present invention, includesthe steps of providing a molded piece and a surgical blade and attachingthe surgical blade onto the molded piece, such that the blade isrestrained mechanically with respect to the molded piece. The moldedpiece with the blade therein is further received within a container, andthe container is sealed and sterilized.

Preferably, a plurality of identical sealed containers, each containinga molded piece with a surgical blade secured therein, are packaged intorespective packages. These packages are further transported to asterilization station (which is typically located off-line) where theyare sterilized.

The sterilization may be conducted by any suitable means available,including (but not restricted to) exposure to ethylene oxide gas, heat,radiation, steam autoclave, etc. subject to the equipment available andthe particular sterilization process adapted by the manufacturingenterprise.

The container can be heat-sealed or ultrasonically welded, again subjectto the equipment available.

In accordance with the still further teachings of the present invention,a surgical blade package includes a surgical blade restrained withrespect to a molded piece, forming thereby a subassembly, which isreceived between an opaque base paper portion and a plastic transparent"blister" upper portion. The base paper portion and the upper "blister"portion are sealed together along their peripheries and extend beyondthe sealing line, thereby providing respective pull tabs.

Viewed in still further aspect, the present invention teaches a surgicalblade package which includes a pouch including a base strip member, atransparent film sealed to the base strip member, and a subassemblycontained within the pouch. The subassembly includes a molded member andfurther includes a surgical blade carried by the molded member, recessedtherein, and restrained mechanically against movement thereon. Thesurgical blade is prevented from becoming dulled due to engagement withthe molded member or the pouch. The pouch, and the subassembly containedtherein, may be readily sterilized.

It will be readily appreciated that an inadvertent or accidental contactwith the surgical blade is precluded by this invention.

These and other objects of the present invention will become apparentfrom a reading of the following specification taken in conjunction withthe enclosed drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a pictorial view of a sterile blade package protected by aremovable foil.

FIG. 2 is a further pictorial view, corresponding to FIG. 1, but showingthe foil being removed for access to the blade package assembly of thepresent invention.

FIG. 3 is a perspective view of the blade package assembly including abase, a blade mounted on the base, and a partial cover pivotably mountedon the base for protecting the blade.

FIG. 4 is a cross-sectional view thereof, taken along the lines 4--4 ofFIG. 3 and drawn to an enlarged scale, and showing an upstanding pin onthe base, the pin being received within a hole in the blade, and furthershowing the rear end portion of the blade supported upon a ledge on thebase, the blade preferably being inclined downwardly towards the pin.

FIG. 5 is a cross-sectional view thereof, taken along the lines 5--5 ofFIG. 4 and showing how the cutting edge of the blade is maintained in aspaced relationship at all times with the blade package assembly,thereby precluding the blade from being dulled inadvertently.

FIG. 6 is a plan outline of the improved blade of the present invention.

FIG. 7 is a pictorial view showing the cleat on the scalpel initiallybeing inserted into the slot on the blade.

FIG. 8 is a further pictorial view, corresponding substantially to FIG.7, but showing the cleat on the scalpel fully seated within the slot onthe blade.

FIG. 9 is a still further pictorial view, corresponding substantially toFIG. 8, but showing the scalpel (with the blade mounted thereon) beinglifted up and away from the base, thereby pivoting the cover, andthereby clearing the hole in the blade from the pin on the base.

FIGS. 10-12 are schematic sequence views, corresponding to FIGS. 7-9,respectively, and showing how the blade may be safely and easily mountedon the scalpel in a matter of seconds.

FIG. 13 is a cross-sectional view, taken along the lines 13--13 of FIG.12 and drawn to an enlarged scale, and showing the detailed constructionof the slot in the blade and the cleat on the scalpel.

FIG. 14 is a cross-sectional view thereof, taken along the lines 14--14of FIG. 13.

FIG. 15 is a pictorial view of a portion of FIG. 3, showing the cover aspreferably transparent.

FIG. 16 is a further pictorial view, showing how a plurality of bladesmay be packaged in a single blade package, the package facilitatingindividual blade selection and mounting.

FIG. 17 is a perspective view of another embodiment of the blade packageof the present invention, showing a frangible film bonded to the base ofthe blade package, the film being partially torn away to show a portionof the blade mounted on the base, and the film having a tab projectingrearwardly of the package for tearing off the film from the base of thepackage.

FIG. 18 is a longitudinal section view thereof, taken along the lines18--18 of FIG. 17.

FIG. 19 is a top plan view of the base only.

FIG. 20 is a side elevation view thereof.

FIG. 21 is an end view thereof.

FIGS. 22 and 23 are schematic sequence views, drawn to an enlargedscale, and showing the hole in the blade being received over the pin onthe base with a slight interference fit.

FIGS. 24 and 25 are further schematic sequence views, drawn to anenlarged scale, and showing the rear portion of the blade being receivedin the notch of the rear end wall on the base with a slight interferencefit.

FIG. 26 is a top plan view of a modified base, wherein the sides of thebase are indented concavely to facilitate gripping the base between thethumb and forefinger.

FIG. 27 is a side elevation thereof, showing serrations or grooves onthe concave indents to facilitate gripping.

FIG. 28 is a further modification of the base, showing a depending panelfor alternate gripping of the base.

FIG. 29 is an end view thereof, showing the depending panel joined tothe base by a "living" hinge for compactness of the blade package inshipment and storage.

FIG. 30 is a modification of the pin on the base, showing a "mushroom"cap on the pin, thereby facilitating a "snap" fit.

FIG. 31 is a modification of the notch on the base, showing respectiveprotrusions to facilitate receipt of the base with a "snap" fit.

FIG. 32 shows diagrammatically a preferred embodiment for manufacturingthe surgical blade packages according to the present invention.

FIG. 33 shows schematically the sequence of the operations of FIG. 32.

FIGS. 34 and 35, respectively, show schematically a production line,wherein a plurality of surgical blade packages are manufacturedaccording to the preferred method of the present invention.

DESCRIPTION

With reference to FIGS. 1-3, a sterile blade package 10 (FIG. 1) iswrapped in an aluminum foil 11 which is torn open (FIG. 2) in the O.R.(or other medical or hospital environment) to obtain the blade packageassembly 12 of the present invention (FIG. 3).

With further reference to FIGS. 4 and 5, the blade package assembly 12preferably comprises a single molded article and includes a base 13 anda cover 14 pivoted thereto by means of an integral reduced cross-section"living" hinge 15. The cover 14 extends partially over the base 13 and,preferably, the cover 14 is transparent (FIG. 15) along with the bladepackage assembly 12.

A blade 16 is mounted on the base 13. As shown more clearly in FIG. 6,the blade 16 has a main body portion 17 provided with a longitudinalslot 18. This slot 18 includes a rearward portion 19 and a narrowedforward portion 20. The blade 16 further has a tip 21, a bottom cuttingedge 22, a hole 23 between the tip 21 and the slot 20, and a rear endportion 24 beyond the slot 20.

The base 13 has an upstanding pin 25 which is substantiallyperpendicular to the pivot axis of the cover 14 and spaced therefrom.This pin 25 is received in the hole 23 in the blade 16, therebypositioning the blade 16 on the base 13. The cover 14, in turn, isprovided with a cushioned pad 26 of foam plastic (or other suitablematerial) to trap the blade 16 between the base 13 and the cover 14.

The base 13 further has a ledge 27 supporting the rear end portion 24 ofthe blade 16. Preferably, the ledge 27 is elevated so that the blade 16is canted downwardly, as shown more clearly in FIG. 4. The base 13further has a pair of spaced-apart raised lands 28 and 29, respectively,one on each side of the ledge 27.

This arrangement prevents undesired movement of the blade 16 (whichwould otherwise inadvertently dull the cutting edge 22 of the blade 16).

The operation of the invention and its inherent features and advantagesare illustrated in FIGS. 7-12, respectively.

The blade 16 is mounted on the forwardly-extending cleat 30 of asurgical scalpel 31. Preferably (but not necessarily) the scalpel 31 isa guarded surgical scalpel as disclosed and claimed in U.S. Pat. Nos.5,250,063 issued Oct. 5, 1993 and No. 5,275,606 issued Jan. 4, 1994 tothe present inventors (applicants). It will be appreciated by thoseskilled in the art, however, that the present invention is equallyapplicable to conventional non-guarded scalpels, if desired.

As shown more clearly in FIGS. 7 and 10, the cleat 30 on the scalpel 31is initially inserted into the rearward portion 19 of the slot 18 in theblade 16. The cleat 30 is then advanced forwardly such that the cleat 30is fully seated within the slot 18 (which may be with a slight "click"or "snap" fit) as shown more clearly in FIGS. 8 and 11. Thereafter, thescalpel 31 with the blade 16 mounted thereon is lifted up and away fromthe base 13 (FIGS. 9 and 12) to pivot the cover 14 away from the base 13and, more significantly, to clear the hole 23 in the blade 16 from thepin 25 on the base 13.

The entire operation of thus mounting the blade 16 on the scalpel 31 iseasy and convenient, takes only a few seconds, and assures that the userwill not be cut or nicked accidentally.

With reference to FIGS. 13 and 14, the cleat 30 on the scalpel 31 has agroove 32 formed therein to receive the slot 18 on the blade 16. Theseblades 16 are in widespread use in hospitals and clinics. However, itwill be appreciated by those skilled in the art that the presentinvention is not necessarily confined thereto but, rather, is equallyapplicable to other surgical blade designs and configurations.

With reference to FIG. 16, the teachings of the present invention areequally applicable to a multi-blade package 33 having a plurality ofblades 16 in a side-by-side relationship therein. This multi-bladepackage 33 would be contained in a single sterile package (not shown)which would be opened in the O.R.

The surgical scalpel blades 16 are razor sharp and can become dulledvery quickly during a surgical procedure. It is important for thesurgeon to have a very sharp "fresh" blade readily available. During atypical operation, the blades 16 may be changed around a half dozentimes. This invention assures that the blades 16 may be quickly, easilyand safely mounted on the scalpel 31 during the surgical procedure.

Moreover, it is significant that the blade does not move during themounting process (unlike the prior art razor blade dispensers andinjectors) and that the mounting of the blade involves basically twosteps: first, insertion of the scalpel and, second, lifting of thescalpel (with the blade thereon) to pivot the cover and clear the bladepackage assembly. This movement is foolproof, convenient, safe, takesonly a few seconds, and is readily understood by the O.R. techs,assistants and surgeons.

As disclosed herein, the mounting of the blade on the scalpel isbasically a two-hand operation: one hand holding the blade packageassembly 12, and the other hand holding the scalpel 31. However, ifdesired, a ledge or suitable mounting may be provided on the tray table(not shown) for retaining the blade package assembly 12, so that onlythe scalpel 31 is held. This is a one-hand operation.

With reference to FIGS. 17 and 18, the blade package 100 includes a base101 supporting a blade 102, and a thin film 103 covers the blade 102 andis bonded to the base 101 by a suitable known method, such as heatsealing or ultrasonic welding. The film 103 is of polyethylene (or othersuitable material) and, preferably, is transparent so that the blade 102is visible in the package 100. The package 100, with the blade 102therein, can be sterilized by radiation or by gas (ethylene oxide)depending upon manufacturing preferences.

The film 103 has at least a frangible portion and, preferably, a tab 104is formed integrally with the film 103 to facilitate rupturing orpeeling off the film 103 and lifting it up and away from the base 101.In this embodiment of the invention, the tab 104 projects rearwardly ofthe base 101 and has a substantially triangular plan outline; however,other plan outlines of the tab 104, as well as other means for tearingoff or rupturing the film 103, are feasible consonant with the teachingsof the present invention.

With reference to FIGS. 19-21, the base 101 is substantially rectangularor obling (although other shapes are possible) and has side walls 105,106 and end walls 107, 108, respectively, and a bottom wall 109. Thebottom wall 109 has an upstanding portion 110 (which, preferably, iscored out to reduce material) and is provided with an upstandingintegrally-formed pin 111; and the end wall 108 of the base 101 has anotch 112 formed therein.

The blade 102 has a rear portion 113 received in the notch 112 formed inthe end wall 108 of the base 101, and the blade 102 further has a hole114 formed therein to receive the pin 111 on the base 101, as shown moreclearly in FIGS. 17 and 18. Preferably, the blade 102 is substantially"straight" on the base 101, that is, substantially parallel to thebottom wall 109, as shown in FIG. 18, although the blade 102 may beslightly inclined in the package 100 (if desired).

With reference to FIGS. 22 and 23, the diameter of the pin 111 isgreater than the diameter of the hole 114 in the blade 102, such thatthe pin 111 is received in the hole 114 with a slight press-fit orinterference fit. Also, with reference to FIGS. 24 and 25, the rearportion 113 of the blade 102 is received in the notch 102 in the endwall 108 with a slight press-fit or interference fit. The plasticmaterial of the base 101 is thereby distorted, somewhat, as the blade102 is "popped" into the base 101 with a "snap" fit during themanufacturing process.

With reference to FIGS. 26 and 27, the respective side walls 105 and 106of the base 101 are indented concavely (FIG. 26) and these concaveindents 115 and 116, respectively, are preferably formed with serrationsor parallel grooves 117 (FIG. 27) to facilitate gripping the base 101between the thumb and forefinger as the tab 104 is pulled to rupture thefrangible film 103 and lift it up and away from the base 101.

Thereafter, the blade 102 may be mounted on the scalpel handle in amanner similar to the embodiment of FIGS. 7-12 and, it will beappreciated, the leverage exerted by the scalpel handle will cause theblade 102 to "pop" out of the base 101 of the package 100.

The base 101 is a simple, lightweight low-cost molded plastic piece; andthe mold for the base 101 will not have any "side pulls", therebyreducing the mold costs and the cycle time.

With reference to FIGS. 28 and 29, the base 101 may have a dependingpanel 118 for gripping purposes, if desired. If so, the panel 118 may bejoined to the base 101 by a "living" hinge 119, so that the panel 118may be folded up against the base for compactness in shipping andstorage.

With reference to FIG. 30, and again if desired, the pin 111 may have a"mushroom" cap 120 providing an annular shoulder 121, and with referenceto FIG. 31, the sides 122 of the notch 112 may have protrusions orridges 123, to improve the interference fit.

With reference again to FIG. 18, the blade 102 is disposed below theperipheral rim 124 of the base 101.

It will be appreciated by those skilled in the art that the bladepackages of the present invention are substantially safer, moreconvenient and easier to use, and readily sterilizable. Moreover, theblade packages of the present invention are less expensive tomanufacture. This is particularly the case with the improved bladepackage of FIGS. 18-27, wherein the base is a simple low-cost moldmentrequiring no side pulls, the blade is snapped into the base and isretained therein against movement, and the film is disposed over theblade and is readily bonded to the base. This film is transparent sothat the blade is visible at all times.

With reference to FIGS. 32-35, the preferred process of manufacturingthe surgical blade package of the present invention includes the stepsof providing molded pieces 100 and surgical blades 102 and automatically(or manually) attaching each blade 102 to the molded piece 100 such thatthe blade 102 is restrained mechanically (as best shown in FIGS. 17, 18,22-25, 30, 31 and 33-35).

As best shown in FIGS. 34 and 35, the molded pieces 100 attached to eachother can be supplied to the production line 103, and each blade 102will be loaded to a respective one of a plurality of the molded pieces100. When "stuffed" with the blade 102, the molded pieces are separatedby cut-off means 127 known to those skilled in the art and schematicallyshown in FIGS. 34 and 35. Each subassembly 128 (including the moldedpiece 100 and the blade 102) is further placed into a container 129. Aplurality of the containers (also referred to as pouches) 129 aresupplied to the production line 126 (as described below) such that theseparated individual subassembly 128 can be automatically inserted intothe pouch 129 which is supplied to the production line 126 and ready toreceive the subassembly 128.

The containing means (or the pouch) 129 may be any sterilizable envelopefor retaining the subassembly before, during and after sterilization andfor maintaining sterility of the contents for extended period of time.The material of the containing means 129 should be mechanically durableand rupture resistant; it also should be penetrable for a sterilizationmedia adapted at the manufacturing facility, such as withstanding (andpermeable to) autoclave, gas, radiation, etc. etc. sterilization.

The containing means or pouch 129 may be a thin plastic bag, a thinmolded ampoule, a dual-layer envelope, etc.

As best shown in FIGS. 33-35, the pouch 129 includes an opaque basemember (also referred to as a strip base member) 130, such as, forinstance, a paper strip, and further includes a transparent material,such as a plastic transparent film or a molded transparent plasticpiece, forming a recess or a "blister" pack, and referred to herein asan upper portion 131.

The subassembly 128 is positioned between the base member 130 and thepre-molded "blister" (or the film) upper portion 131; and the basemember (base strip member) 130 made of the paper and the plastic upperportion 131 are sealed together around the periphery of the container129 forming a sealing line 132.

Paper is used because of its ease of fabrication, its economy, and itsability to permit sterilization of the enclosed subassembly 128 (as, forinstance, by gas sterilization).

Also, the opaque paper of the base member 130 allows for printing therequired labels, words or symbols, date of sterilization, etc. that areimportant for quality control and marketing purposes.

The transparent plastic of the upper portion 131 allows for the identityof the contents to be easily ascertained by a visual inspection.

The plastic "blister", or the plastic film, of the upper portion 131 andthe paper of the base member 130 should be flexible yet have sufficientstrength to allow the pouch 129 to be safely handled and stored whilebeing capable of withstanding the conditions of sterilization. The upperportion 131 and/or the base member 130 should be permeable to steam andsterilizing gas (for instance, ethylene oxide gas) or capable of beingsterilized by other methods, while at the same time being substantiallyimpervious to dust and bacteria.

After positioning the subassembly 128 between the base member 130 andthe plastic upper portion 131, they are sealed together along theirperiphery in any desired manner which provides a semi-permanent, dustand bacteria-free seal which is capable of both withstandingsterilization conditions and of being easily opened by separating theplastic and the paper so that the subassembly 128 is not contaminated bycontact with the external portions of the pouch 129.

If the pouch 129 is a plastic "bag", or a thin molded ampoule, then thesubassembly 128 is slipped into the "bag", and the "bag" sealed at oneside which was opened for receiving the subassembly 128. The heatsealing may be performed in a conventional and well known manner, as bythe use of a heated roller die (for example) or other suitable means.The die is designed to form a seal line which closes the pouch 129completely to provide a hermetically sealed unit. The paper base member130 and the plastic upper portion 131 extend beyond the seal line 132 toform respective pull tabs 133 for convenient opening of the pouch whenneeded in the O.R.

On the production line 126, as best shown in FIGS. 34 and 35, theplastic for a transparent upper portion 131 is supplied as a continuousplastic sheet 134 from a roll 135 which is unwound by a suitablemechanism (not shown). The plastic sheet 134 moves through a formingsection 136 in the production line 126 where the "blisters" are formed.The shape and dimensions of the "blisters" can be easily varied. Aplurality of these "blisters" moves from the forming section 136 to aloading section 138 where the subassemblies 128 are loaded; eachsubassembly 128 is loaded into a respective "blister" (upper portion)131. Preferably, the loading is performed automatically. The loadedplastic "blisters" move towards a sealing station 139 where they are"covered" by the paper sheet 140 which is sealed to the "blisters" by aheated die to form the seal line 132 and the pull tabs 133. At across-cutter section 141, a shearer 142 containing a cutting means,makes a cross-cut across a row of the sealed pouches 129; further at aslitting area 143, a slitter (consisting of knives or any suitableslitting means, not shown) separates the pouches 129. The finishedpouches 129, containing the respective subassemblies 128, are dischargedfrom the production line 126, packaged in a packaging area 144, andtransported to a sterilization station 145.

With the pouches 129 formed as described above, the subassembly 128 maybe sterilized in a conventional manner as by autoclaving, flushing withethylene oxide, gamma radiation, steaming, etc. Due to thesemi-permeability of the paper base member 130 to gas and theaccompanying moisture vapor, the sterilization by ethylene oxide gas canbe performed in just one step.

From the aforesaid, it will be appreciated by those skilled in the artthat the surgical blade package of the present invention has thefollowing features and advantages:

Low material cost.

Readily adaptable to high-speed automated production.

The surgical blade 102 is prevented from becoming dulled due toengagement with the molded member 100 or the pouch 109.

The pouch 129, and the subassembly 128 of the molded member 100 andsurgical blade 100 contained therein, may be readily sterilized.

Easy and convenient to use.

Handling and mounting a scalpel blade.

Precludes inadvertent or accidental contact with the surgical blade.

Obviously, many modifications may be made without departing from thebasic spirit of the present invention. Accordingly, it will beappreciated by those skilled in the art that within the scope of theappended claims, the invention may be practiced other than has beenspecifically described herein.

We claim:
 1. A surgical blade package comprising:a surgical blade, amolded piece, a base member, and an upper portion, wherein the surgicalblade is mechanically restrained with respect to the molded pieceforming thereby a subassembly, wherein the upper portion is shaped toform a recess, wherein said subassembly is received within said recessbetween the base member and the upper portion, which are sealedtogether, wherein the blade is intended to be mounted on the cleat of ascalpel handle, and wherein the blade is provided with a slot having aforward portion and is further provided with a cutting edge, said moldedpiece further comprising: a base, means on the base for supporting theblade and assuring that the cutting edge on the blade will not becomedulled by inadvertent contact with the base during shipment, storage orhandling of the molded piece, wherein the cleat on the scalpel handlemay be inserted into the slot in the blade to mount the blade on thescalpel handle, and such that the blade mounted on the scalpel handlemay be lifted out of the base of the molded piece, wherein the means onthe base for supporting the blade and assuring that the cutting edge onthe blade will not become dulled by inadvertent contact with the baseduring shipment, storage or handling of the blade package, comprises anupstanding pin on the base, the blade having a hole formed therein toreceive the pin; wherein the hole in the blade is disposed between thetip of the blade and the forward portion of the slot in the blade;wherein the blade further has a tip and a rear portion, and wherein thebase has a rear end wall having a notch formed thereon and receiving therear portion of the blade; and wherein said surgical blade packagefurther includes an interference fit between the pin and the hole, andbetween the notch and the rear portion of the blade, respectively, suchthat the blade is received on the base with a "snap" fit.